The following data is part of a premarket notification filed by Genetic Laboratories, Inc. with the FDA for Suture Strip.
Device ID | K842621 |
510k Number | K842621 |
Device Name: | SUTURE STRIP |
Classification | Strip, Adhesive, Closure, Skin |
Applicant | GENETIC LABORATORIES, INC. 1385 DENTENNIAL DRIVE St. Paul , MN 55113 - |
Contact | Daniel G Holman |
Correspondent | Daniel G Holman GENETIC LABORATORIES, INC. 1385 DENTENNIAL DRIVE St. Paul , MN 55113 - |
Product Code | FPX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-05 |
Decision Date | 1984-10-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUTURE STRIP 74021832 1697316 Live/Registered |
Genetic Laboratories Wound Care, Inc. 1990-01-23 |
SUTURE STRIP 73481080 1370707 Dead/Cancelled |
GENETIC LABORATORIES, INC. 1984-05-21 |